Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)
Status: | Completed |
---|---|
Conditions: | Hepatitis, Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/24/2017 |
Start Date: | July 2014 |
End Date: | December 2015 |
Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis C (FOURward Study)
The purpose of the study is to determine whether the combination of Daclatasvir (DCV),
Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C
virus.
Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C
virus.
Allocation:
Initial Therapy: Randomized Controlled Trial: Participants are assigned to intervention
groups by chance
Rescue Therapy: Nonrandomized Trial: Participants are expressly assigned to intervention
groups through a non-random method such as physician choice
Number of Arms:
Initial Therapy: 2 Groups
Rescue Therapy: 2 Groups
Initial Therapy: Randomized Controlled Trial: Participants are assigned to intervention
groups by chance
Rescue Therapy: Nonrandomized Trial: Participants are expressly assigned to intervention
groups through a non-random method such as physician choice
Number of Arms:
Initial Therapy: 2 Groups
Rescue Therapy: 2 Groups
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.
Inclusion Criteria:
- Males and Females ≥18 years of age, inclusive
- Chronic HCV infection Genotype 1 only
- Non-cirrhotic
- Treatment naive subjects with no previous exposure to an Interferon formulation (ie,
IFNα, pegIFNα), ribavirin (RBV) or HCV Direct Acting Antiviral (DAA) (protease,
polymerase inhibitor, etc.)
Exclusion Criteria:
- HCV Genotype other than Genotype 1
- Documented or suspected hepatocellular carcinoma
- Evidence of decompensated liver disease
- Contraindication(s) to Peg/RBV therapy
We found this trial at
5
sites
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303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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